MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ROTATOR SNARE OVAL

Model Number	00711120
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up with the distributor, steris endoscopy learned that the snare loop became stuck on the polyp during the patient procedure.The snare loop had to be cut with a pair of scissors to be removed from the polyp.The device was then successfully removed from the scope.The device history record was reviewed and confirmed that the device was manufactured to specification.There have been no other complaints associated with this lot.The rotator¿ - snare - oval instructions for use states, "short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, are recommended throughout device passage to avoid sheath kinking.This device is not designed for use in side viewing endoscopes.The following conditions may not allow a snare device to function properly: advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or actuating the device when the handle is at an acute angle in relation to the sheath.Check the active cord for secure connection to the snare handle and the electrosurgical generator.Ensure that the return electrode is secure and properly connected to the patient and the electrosurgical generator.Consult the electrosurgical generator manufacturer's instructions for use for proper settings and use of the generator.The distributor provided in-service training on the proper use and operation of the rotator snare.No additional issues have been reported.
Event or Problem Description
The distributor reported that during a patient procedure their rotator snare would not cut through a polyp.No report of patient harm.The procedure was completed successfully.

• Brand Name: ROTATOR SNARE OVAL
• Common Device Name: ROTATOR SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 13552443
• Report Number: 1528319-2022-00010
• Device Sequence Number: 5256638
• Product Code: FDI
• UDI-Device Identifier: 00724995182649
• UDI-Public: 00724995182649
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00711120
• Device Catalogue Number: 00711120
• Device Lot Number: 2102608
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/17/2022
• Date Device Manufactured: 03/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown